Kornimate/medical-research-clean huggingface dataset:
a study of xevinapant (debio 1143) in combination with platinum-based chemotherapy and standard fractionation intensity-modulated radiotherapy in participants with locally advanced squamous cell carcinoma of the head and neck, suitable for definitive chemoradiotherapy (trilynx)

Conditions: Squamous Cell Carcinoma of the Head and Neck

Summary: the primary objective of the study is to demonstrate superior efficacy of xevinapant (debio 1143) vs placebo when added to chemoradiotherapy (crt) in locally advanced squamous cell carcinoma of the head and neck (la-scchn).


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group performance status (ecog ps) 0 or 1 * histologically confirmed diagnosis of previously untreated locally advanced squamous cell carcinoma of the head and neck (la-scchn) participant (stage iii, iva or ivb according to the american joint committee on cancer(ajcc))/classification of malignant tumors: t=size of the primary tumor, n=regional lymph node involvement, m=distant metastasis (tnm) staging system, 8th edition.) suitable for definitive chemoradiotherapy (crt), of at least one of the following sites: oropharynx, hypopharynx and larynx * for oropharyngeal cancer (opc) participants, primary tumors must be human papillomavirus (hpv)-negative as determined by p16 expression using immunohistochemistry * evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography scan (ct-scan) or magnetic resonance imaging (mri), based on response evaluation criteria in solid tumors (recist) version 1.1 * peripheral neuropathy less than (\<) grade 2 * adequate hematologic, renal and hepatic function * other protocol defined inclusion criteria may apply exclusion criteria: * primary tumor of nasopharynx, paranasal sinuses, nasal or oral cavity, salivary, thyroid or parathyroid gland pathologies, skin or unknown primary site * metastatic disease (stage ivc as per ajcc/tnm, 8th ed.) * prior definitive or adjuvant radiotherapy (rt) and/or radical surgery to the head and neck region which may jeopardize the primary tumor irradiation plan, or any other prior scchn systemic treatment, including investigational agents * documented weight loss of \>10% during the last 4 weeks prior to randomization (unless adequate measures are undertaken for nutritional support), or plasmatic albumin \< 3.0 g/dl. no albumin transfusions are allowed within 2 weeks before randomization * known allergy to xevinapant (debio 1143), cisplatin, carboplatin, other platinum-based agent or any excipient known to be present in any of these products or in the placebo formulation * other protocol defined exclusion criteria may apply

Keywords: trilynx
efficacy and safety study of me1111 in patients with onychomycosis

Conditions: Onychomycosis

Summary: the purpose of the study is to determine the safety and efficacy of high and low strength of me1111 solutions compared to the vehicle in the treatment of onychomycosis of the toenail.


Eligibility criteria:
inclusion criteria: * mild to moderate distal lateral subungual onychomycosis * a positive potassium hydroxide (koh) microscopy * a positive fungal culture for a dermatophyte * good general health exclusion criteria: * uncontrolled diabetes * onychomycosis of the fingernails * prior use of antifungal drugs (failure to complete the specified washout period) * history of hiv, hepatitis b or hepatitis c * diagnosis of psoriasis or history of psoriasis * participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study * pregnancy/lactation
a novel multiplex elisa assay for surveilling patients with history of bladder cancer

Conditions: Bladder Cancer

Summary: voided urinary cytology (vuc) is the most widely used urine-based assay for detecting bladder cancer (bca); however, it fails to detect approximately 50% of low-grade or early stage bca when it is most curable. furthermore, the detection rate of vuc for recurrent bca is not much better. because of this severe limitation, all patients who are under surveillance to monitor for recurrent bca must undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder and the bladder inspected (cystoscopy). we propose to improve the non-invasive detection of recurrent bca by further validating a multiplex elisa assay directed at a bca-associated diagnostic signature in voided urine samples.


Eligibility criteria:
inclusion criteria participants must be: * age 18 years or older * have a history of non-muscle invasive bladder cancer or muscle invasive bladder cancer treated by bladder sparing techniques (or not yet treated) and diagnosed within the past 24 months on cystoscopic surveillance * participants may be treated with adjuvant intravesical therapy * willing and able to give written informed consent (see appendix 1) * be willing to adhere to the surveillance regimen (high risk and intermediate risk seen every 3 months for 2 years; low risk seen every 6-12 months for 2 years) exclusion criteria: participants must not: * have had radical cystectomy * history of previous cancer (excluding bladder, basal and squamous cell skin cancer) within the past 3 years * have a known active urinary tract infection or urinary retention * have active stone disease (renal or bladder) or renal insufficiency (creatinine \>2.0 mg/dl) - serum creatinine value can be up to 60 days before consent, otherwise repeat. * have ureteral stents, nephrostomy tubes or bowel interposition * have recent genitourinary instrumentation (within 10 days prior to signing consent) * be unable or unwilling to complete the surveillance regimen
double dose 4-ap on functional recovery after spinal cord injury

Conditions: SCI - Spinal Cord Injury

Summary: the purpose of this study is to test a strategy to potentiate functional recovery of lower limb motor function in individuals with spinal cord injury (sci). the fda approved drug, dalfampridine (4-ap). 4-ap will be used twice-daily in combination of spike-timing-dependent plasticity (stdp) stimulation and stdp stimulation with limb training.

currently, research has shown that 4-ap has a positive effect on sensory and motor function rehabilitation in humans with chronic sci in addition to decreasing recorded spasticity, increased sensation, and decreased pain. a pharmacokinetic study showed that twice-daily administration of sustained release 4-ap maintains a steadier plasma concentration. utilizing limb training to promote recovery of motor function is enhanced by eliciting stdp in the limbs. an important strength of this aim is the combination of training and stdp, which aims to enhance the beneficial effects of motor training by promoting plasticity in the corticospinal pathway. training effects on physiological pathways will be explored and correlated with lower limb motor function. we hypothesize that introducing 4-ap into the stdp stimulation and stdp stimulation with training will further improve motor function rehabilitation in patients with chronic sci.

Eligibility criteria:
inclusion criteria: * male and females between ages 18-85 years * sci 6 months post injury * spinal cord injury at or above l2 * asia a, b, c, or d, complete or incomplete * the ability to perform a small visible contraction with dorsiflexion and hip flexor muscles exclusion criteria: * uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease * any history of renal impairment * any debilitating disease prior to the sci that caused exercise intolerance * premorbid, ongoing major depression or psychosis, altered cognitive status * history of head injury or stroke * vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without history of seizure, and without anticonvulsant medication * history of seizures or epilepsy * receiving drugs acting primarily on the central nervous system, which lower the seizure threshold (see appendix 2) * pregnant females * if a women of child bearing age is unsure of the pregnancy, and does not want to take the pregnancy test * ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida, ms, or herniated disk * metal plate in skull * individuals with scalp shrapnel, cochlear implants, or aneurysm clips * individuals taking bupropion, dolutegravir, lacosamide, trilaciclib, or pr interval prolonging drugs

Keywords: spinal cord injury neurostimulation 4-ap rehabilitation
gaming open library for intervention in autism at home (goliah /michelangelo)

Conditions: Autism Spectrum Disorder

Summary: to meet the required intensive intervention hour for treating children with autism spectrum disorder (asd), the investigators developed an automated serious gaming platform (11 games) to deliver intensive intervention at home (goliah). the major objective of the study is to test goliah during a 6-month matched controlled exploratory study were to assess (1) the usefulness and acceptability of the gaming platform; (2) how experimental children performed using the different imitation and ja games; and (3) whether children from the experimental group improved significantly more than children treated as usual (control group).

background: to meet the required intensive intervention hour for treating children with autism spectrum disorder (asd), the investigators developed an automated serious gaming platform (11 games) to deliver intensive intervention at home (goliah) by mapping the imitation and joint attention (ja) subset of age-adapted stimuli from the early start denver model (esdm) intervention. for the purpose of this study, 24 asd children will be recruited (one half in pisa and the other half in paris). they will be divided into two groups: an experimental group (n=14) and a control group (n=10). the control group will not go through the training sessions, they will participate only in the assessment sessions. all patients will be referred to treatment as usual, according to local facilities. the protocol is organized into 3 periods (with two assessments at t0 and t6). * during the initial stage of the protocol (t0), all the asd children (experimental participants and controls) will be evaluated during a clinical session. * during the rehabilitation period, only half of the children will participate in the training sessions designed to improve their imitation and joint attention capacities. * during the final stage of the protocol (t6), all children will be evaluated again during a second clinical session. the clinical assessments will occur at stage 0 and at stage 6. the same tools will be used for these two assessments. the improvement of children's capabilities will be measured by the progress made between stage 0 and stage 6. the investigators will be able to affirm that the training was beneficial by comparing the clinical session performance between the trained and control children.

Eligibility criteria:
inclusion criteria: * a current diagnosis of asd confirmed by clinical assessment and the autism diagnostic interview-revised; * an intellectual quotient ≥ 60; * aged between 5 to 8 years. * inclusion in the experimental group was based on parents' motivation to follow such a heavy protocol both at home and for the one session per week at the hospital. * controls were matched for sex, age, iq, study sites and treatment. exclusion criteria: * known organic syndrome and/or non-stabilized neuropediatric (e.g. seizures) or medical (e.g. diabetes mellitus) comorbidities.

Keywords: autism spectrum disorder serious game controlled trial denver model
from addiction to employment.

Conditions: Substance Use Disorders

Summary: patients with substance use disorders have low employment rates and are to a large extent on the outside of the ordinary labor market. individual placement and support (ips) is an evidence based method developed to aid persons with severe mental disorders in obtaining ordinary work. ips has been used clinically in the addiction field, but has been subject to little research. the trial "from addiction to employment" is a randomized controlled trial to investigate the effect of an ips intervention on employment outcome among substance use disorder patients in specialized health care treatment in oslo, norway. the study is conducted at the department for substance use disorder treatment at oslo university hospital. the trial begins to include patients march 1st 2020 and will include for two years, until february 28th 2022.

the target population in this project is patients in sud treatment who wish to gain employment. the goal of the study is to determine the effectiveness of ips in helping persons with sud obtain ordinary employment. a pragmatic, two-arm, parallel, superiority, randomized controlled trial will be conducted. the project is financed through innovation funding from the south eastern norway regional health authority, the norwegian directorate of health and internal resources from ous. participants will be allocated randomly to either an employment specialist whom they will have individual contact with for the coming 13 months or shorter (intervention), or to a self-help and four-sessions work shop intervention (control comparison). the intervention fidelity will be assessed by external evaluators according to the norwegian translation of the ips fidelity scale. patients will be recruited to the study over a period of two years, and followed for 18 months my data collection and up until 10 years in national registries.

Eligibility criteria:
inclusion criteria: * in treatment, unemployed, want to obtain ordinary, competitive employment exclusion criteria: * coercive treatment that disables the patient to engage in the intervention
a safety, efficacy and tolerability trial of pregabalin as add-on treatment in pediatric and adult subjects with primary generalized tonic-clonic (i.e., grand mal) seizures.

Conditions: Generalized Tonic Clonic Seizures

Summary: the study is designed to evaluate the safety, tolerability and efficacy of two doses of pregabalin as add-on treatment in pediatric and adult subjects with primary generalized tonic-clonic (pgtc) seizures as compared to placebo. it is hypothesized that both doses of pregabalin will demonstrated superior efficacy when compared to placebo by reducing pgtc seizure frequency and that pregabalin will be safe and well tolerated.


Eligibility criteria:
inclusion criteria: * seizures classified as primary generalized tonic clonic seizures * must have at least 1 pgtc seizure in the 8 weeks prior to screening * must have a minimum of 3 pgtc seizures during the 8-week baseline phase and at least 1 pgtc in each 4-week period of the baseline phase * currently receiving adequate and stable dosage of 1 to 3 anti-epileptic treatments (stable within 28 days of screening) * signed informed consent and assent if a minor * ability to comply with daily seizure and dosing diary requirements and all study procedures exclusion criteria: * a current diagnosis of febrile seizures, or seizures related to an ongoing acute medical illness * focal seizures (simple partial, complex partial, or partial becoming secondarily generalized) * status epilepticus within 1 year prior to screening * lennox-gastaut syndrome, infantile spasms, benign epilepsy with centrotemporal spikes (bects) and dravet syndrome * seizures related to drugs, alcohol, or acute medical illness * any change in anti-epileptic treatment regimen (type of medication or dose; vns alteration) within 28 days of the screening visit or during the baseline phase * progressive or potentially progressive structural cns lesion or a progressive encephalopathy. * progressive inborn errors of metabolism.

Keywords: primary generalized tonic clonic seizures epilepsy safety efficacy tolerability pregabalin lyrica adjunctive treatment placebo controlled blinded
efficacy of preoperative intravenous dexamethasone in primary total knee arthroplasty

Conditions: Postoperative Pain

Summary: to determine efficacy of preoperative iv dexamethasone for postoperative pain control after tka.

preoperative intravenous over 0.1 mg/kg of dexamethasone could be reduced pain after primary tka.

Eligibility criteria:
inclusion criteria: * osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty * 50-85 years old * asa class 1-3 exclusion criteria: * unable to perform spinal anaesthesia * history of drug allergies: steroids * renal impairment (crcl \<30 ml/min) * liver impairment * cognitive function disorders * poor controlled dm (ha1c \> 7.5) * morning dtx at operative day \> 180 mg% * received corticosteroids within 3 months before surgery

Keywords: total knee arthroplasty pain control dexamethasone steroids
pgs on blastocysts from vitrified and fresh oocytes

Conditions: Increase the Number of Blastocyst to Biopsy for Preimplantation Genetic Testing

Summary: oocyte accumulation by vitrification is a valid strategy to increase the number of available embryos for biopsy and the number of viable euploid embryos to transfer after preimplantation genetic testing.

in the present study, the investigators considered the hypothesis to accumulate vitrified oocytes with a view to increasing the number of oocytes for micro-injection and consequently the number of blastocyst to diagnose for patients with normal ovarian reserve and candidate for pgt. the partecipants were proposed to undergo several cycles of ovarian stimulation. in the first cycles, mature (metaphase ii) oocytes were vitrified and consequently accumulated. in the last cycle, the freshly produced mature oocytes and the previously accumulated ones were micro-injected together with the same partner's semen sample. pgt was performed on blastocysts produced from the two sources of oocytes. the comprehensive chromosomal analysis of biopsied trophectoderm cells was performed using ngs technology. the number of available euploid blastocyst and the proportion of euploid/aneuploidy embryos from fresh and vitrified/warmed oocytes were compared. in conclusion the investigators evaluated the efficacy of oocyte accumulation by vitrification in increasing the number of available embryos for biopsy and the number of viable euploid embryos to transfer after pgt.

Eligibility criteria:
inclusion criteria: * infertile women * normal ovarian reserve * with repeated implantation failure or reccurent miscarriage * undergoing icsi and asking to know the state of health of the embryos prior to embryo transfer

Keywords: aneuploidy next generation sequencing oocyte vitrification preimplantation genetic diagnosis preimplantation genetic screening
feasibility of centralized therapeutic drug monitoring of fluoroquinolones in multi-drug resistant tuberculosis patients

Conditions: Tuberculosis, Multidrug-Resistant

Summary: observational, multi-centre, prospective study to investigate the feasibility of centralized tdm of moxifloxacin and levofloxacin in mdr-tb patients by determining turn-around time between sampling and receiving dosing advice. in addition, the effect of tdm will be evaluated by comparing treatment results of prospective patients receiving tdm with historical controls without tdm.


Eligibility criteria:
inclusion criteria: * pulmonary mdr-tb * sputum smear and sputum culture positive at baseline * oral administration of either moxifloxacin or levofloxacin * written informed consent (for use of the medical data) exclusion criteria: * pregnancy or breast feeding

Keywords: centralized therapeutic drug monitoring fluoroquinolones
modified lpb and spb vs classical lpb and spb

Conditions: Anesthesia, Local

Summary: the timing of surgery for hip fractures is crucial for elderly patients. the mortality rate for elderly patients after hip fracture is high, and anesthetic decisions significantly affect the patient's outcome. regional anesthesia has been shown to have better outcomes than general anesthesia. we proposed a newly developed modified position for the ultrasound-guided combined anterior lumbar and lateral sacral plexus block technique that offers benefits, including minimizing interference with circulation and anesthesia, avoiding position change and pain, and providing effective postoperative analgesia.

the increasing proportion of elderly patients requiring surgery, particularly for hip fractures, is common among the elderly. the timing of surgery for hip fractures is crucial and most require surgical treatment. the mortality rate for elderly patients after hip fracture is high, and anesthetic decisions significantly affect the patient's outcome. elderly patients have decreased physiological function and are more susceptible to postoperative complications, such as delirium, constipation, pressure sores, and catheter-related infections. regional anesthesia has been shown to have better outcomes than general anesthesia. we proposed a newly developed modified position for the ultrasound-guided combined anterior lumbar and lateral sacral plexus block that offers benefits, including minimizing interference with circulation and anesthesia, avoiding position change and pain, and providing effective postoperative analgesia. the study validates the feasibility and effectiveness of this technique for elderly hip fracture surgery and compares it with a traditional lumbar-sacral plexus nerve block, providing a fresh perspective on anesthesia for this type of surgery.

Eligibility criteria:
inclusion criteria: patients over 70 years of age. asa classification grades ii-iv. patients with hip fractures requiring surgery (intramedullary nailing of intertrochanteric fractures). exclusion criteria: peripheral neuropathy or other neurological disorders affecting the nerves involved in the block; serve coagulopathy or platelet dysfunction; inability to perform puncture due to infection, wound, or other reasons at the puncture site; allergy to local anesthetics or any other medications used in the block; inability to cooperate or communicate with the healthcare provider during the procedure; patients or their families who cannot understand the conditions and objectives of the study.
observation on the immune persistence of people aged 10-60 years old immunized with five doses of rabies vaccine

Conditions: Rabies; Antibody

Summary: evaluation of immune persistence after rabies vaccination in 150 people.

150 subjects aged 10-60 were recruited to inoculate the frozen human rabies vaccine (vero cells) produced and marketed by changchun zhuoyi biological co., ltd. in the whole process of 0, 3, 7, 14 and 28 day immunization. the immunogenicity persistence and safety of the test vaccine were evaluated 14 days, 6 months and 12 months after the whole process of vaccination.

Eligibility criteria:
inclusion criteria: * 10-60 years old； * temperature on the day of admission≤37.0 ° c (axillary temperature). exclusion criteria: * have a history of rabies vaccine immunization or use of rabies virus passive immunization agents； * has been diagnosed with congenital or acquired immunodeficiency disease; * pregnancy (including positive urine pregnancy test) or lactation, planned pregnancy preparation within 2 months.

Keywords: rabies vaccine antibody persistence